BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Accenture
AstraZeneca
Novartis
Johnson and Johnson
Cantor Fitzgerald
Queensland Health
Colorcon
Mallinckrodt

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078722

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NDA 078722 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Twi Pharms Inc, Actavis Labs Fl Inc, Aurobindo Pharma, Frontida Biopharm, Invagen Pharms, Jubilant Cadista, Kvk Tech, Mylan Pharms Inc, Orit Labs Llc, Oxford Pharms, Pliva, Prinston Inc, Rubicon Res Pvt Ltd, Sandoz, Sun Pharm Inds Ltd, Upsher-smith Labs, and Watson Labs, and is included in eighteen NDAs. It is available from seventy-seven suppliers. Additional details are available on the CYCLOBENZAPRINE HYDROCHLORIDE profile page.

The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are fifteen drug master file entries for this compound. Seventy-nine suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 078722
Tradename:CYCLOBENZAPRINE HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:cyclobenzaprine hydrochloride
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 078722
Suppliers and Packaging for NDA: 078722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722 ANDA Aidarex Pharmaceuticals LLC 33261-859 33261-859-02 120 TABLET in 1 BOTTLE, PLASTIC (33261-859-02)
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722 ANDA Aidarex Pharmaceuticals LLC 33261-859 33261-859-30 30 TABLET in 1 BOTTLE, PLASTIC (33261-859-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 12, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:May 12, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 12, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
Fish and Richardson
Argus Health
Medtronic
Mallinckrodt
US Department of Justice
AstraZeneca
Merck
Daiichi Sankyo

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